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FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway
https://www.fda.gov/news-events/press-announcements/fda-permits-sale-two-new-reduced-nicotine-cigarettes-through-premarket-tobacco-product-application
Sorry... truly. Still, it's cheap at current pps.
Great - instead of predicting I should ask for things.
Let's capture .5% market share now.
Congress set to prohibit sales of tobacco products to anyone under 21
https://www.washingtonpost.com/health/2019/12/16/congress-set-prohibit-sales-tobacco-products-anyone-under/
Hopefully, we can at least get the PMTA approval and get into the market...
22nd Century experiences third chief executive departure in five months
https://www.journalnow.com/business/nd-century-experiences-third-chief-executive-departure-in-five-months/article_07b0ce07-fbc0-509a-b5bd-85018018401c.html
Well, this just happened: 22nd Century Group Announces Management Changes
Williamsville, NY, Dec. 13, 2019 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, Very Low Nicotine Content (VLNC) tobacco and hemp/cannabis plant research, announced today changes to the Company’s management.
“Over the past few months we have made rapid and significant progress in strengthening 22nd Century Group as we execute against our two growth strategies,” commented James W. Cornell, Director & Chairman of the Board of 22nd Century Group. “We are committed to creating meaningful change in the tobacco industry by reducing the harm caused by smoking through the commercialization of our proprietary VLNC tobacco and its related intellectual property, and we are growing a profitable, legal hemp/cannabis business in this fast-growing, emerging space.
“Today we are announcing several management changes,” Cornell continued. “First, Cliff Fleet has decided to step away from the role of CEO of 22nd Century while continuing to remain actively engaged in the Company’s leadership as a member of our Board. Cliff has been called to service to lead The Colonial Williamsburg Foundation, which is charged with the stewardship of Colonial Williamsburg, a national, historical treasure. We are happy for Cliff and quite gratified that he will continue as a Director and leader in our organization. In conjunction with this move, we are forming an Executive Committee of our Board, on which Cliff and I will serve, to help guide the Company’s leadership, and Michael Zercher, the Company’s Chief Operating Officer, has been appointed to serve as the Company’s President, effective immediately. Michael is a very talented leader who helped create and is already leading the implementation of the Company’s reshaped strategic plan, and I am confident he will continue providing outstanding leadership of the Company’s day-to-day operations working with Cliff, myself and other members of the Board.”
“Accepting responsibility for leadership of The Colonial Williamsburg Foundation, the world’s largest living-history museum, is a rare honor and very distinctive opportunity,” said Cliff Fleet. “22nd Century is very well positioned for growth as we have recently made a significant investment in the legal hemp/cannabis space, driven rapid progress with both our tobacco-product applications and our hemp/cannabis plant research, raised new capital and tightly controlled costs. As such, I am pleased to continue my involvement with 22nd Century to help oversee the implementation of the strategic plan developed in collaboration with Michael Zercher, our executive management team and 22nd Century’s Board of Directors.”
Cigarette Makers Can Filter Tougher Smoking Rules
https://www.wsj.com/articles/cigarette-makers-can-filter-tougher-smoking-rules-11576150912
https://www.gazettenet.com/Businesses-vapers-blast-Baker-s-vaping-sales-ban-30707107
“If there’s going to be nicotine still sold in cigarettes, I should be allowed to smoke nicotine in a vape, especially if it’s a healthier alternative,”
https://www.aafp.org/news/government-medicine/20191122whitehousevape.html
Has Gottlieb criticized FDA's delay on Twitter? I wonder why not.
22nd Century Group Comments on Delay of Reduced Nicotine Rule for Cigarettes
“22nd Century Group is disappointed that FDA appears to have delayed its efforts to enact a product standard rule to lower the amount of nicotine in all cigarettes sold in the United States to non-addictive levels,” said Cliff Fleet, CEO of 22nd Century Group. “We believe such a rule, when enacted, will dramatically reduce the death and disease caused by cigarette smoking.
“We are encouraged, however, that FDA publicly stated that the Agency continues to work on the nicotine-reduction rule. Furthermore, we remain optimistic about the approval of our Modified Risk Tobacco Product (MRTP) application for very-low nicotine content cigarettes. We believe this application is moving quickly through the Agency’s scientific review process, and we plan to launch this product in the U.S. after we receive an MRTP marketing order for this application.”
As publicly reported yesterday by both Barron’s and CNBC, FDA officials said the omission from the unified agenda does not mean the FDA will stop working on it. FDA representatives Stephanie Caccomo and Michael Felberbaum both said the agency is reviewing comments it received in response to the proposal to cap nicotine levels in cigarettes.
22nd Century Group’s response echoed reactions by various public health advocates and organizations. The American Heart Association issued a statement saying they were “deeply disappointed” that the rule had been delayed. “We urge the FDA and the administration to ensure that protecting public health, particularly the health of our nation’s kids, tops its priority list.” They added that the rule “would have an enormous impact on the millions of cigarette smokers who are currently addicted to products that kill when used as intended.”
“22nd Century continues to believe an industry-wide, national nicotine reduction mandate is the best way to reduce the harm caused by smoking,” said John Pritchard, Vice President of Regulatory Science for 22nd Century Group. “We will continue to vigorously pursue approval of our MRTP application for our VLNC cigarettes, which is unaffected by the timing of the national nicotine reduction rule. Our MRTP application is an opportunity for FDA to make minimally or non-addictive cigarettes available to adult smokers who want them.”
I emailed FDA on 11/18 inquiring about the delay in NPRM- their response:
Thank you for your email. FDA continues to review the more than 7,700 comments received on the Advanced Notice of Proposed Rulemaking regarding this issue. Please continue to watch https://www.fda.gov/tobacco-products for additional information. You may also visit to sign up for email updates on the website https://www.fda.gov/tobacco-products/ctp-newsroom/sign-email-updates-ctp.
Best Regards,
Center for Tobacco Products
Office of Regulations
Let me pull a shelby with a question: Perhaps the timing can be coupled with an NPRM?
Azar in March: support to cut nicotine levels
https://news.bloomberglaw.com/pharma-and-life-sciences/azar-says-u-s-supports-cutting-cigarette-nicotine-levels-1
October passed- we're in the first lagging month now
Ehh... Top Trump official suggests tobacco regulation distracts from FDA mission
https://www.statnews.com/2019/11/08/joe-grogan-fda-tobacco/
“I hate tobacco issues, I always have,” Grogan said. “And FDA shouldn’t be regulating this stuff in the first place.”
Tobacco products should be regulated, Grogan argued — just by a different agency, though he did not specify an alternative. But he drew a line between therapeutic medical products and vices like tobacco. Tobacco “shouldn’t be regulated by a health agency,” Grogan said, since it has “no redeeming qualities.” Grogan clarified that the remarks reflected his personal views, not formal administration stances.
...
Grogan, who has repeatedly clashed with health secretary Alex Azar and helped to derail the administration’s May 2018 drug pricing “blueprint,” also slammed House Speaker Nancy Pelosi’s bill, which Democrats are expected to bring to a vote next month.
...
Apparently those tweets from SG were in response
"CV Sciences CEO Joe Dowling explained on the conference call that competition has intensified greatly in the natural product space, with more than 1000 new brands competing for shelf space. He pointed to low quality products with misleading marketing efforts and labeling crowding the shelves and creating customer confusion."
"We continue to see the media regularly reporting the disappointment of farmers growing hemp. They are finding it difficult to find buyers and face lower prices than they expected. Litigation abounds, as well, with several cases of rampant fraud, including some companies that have allegedly sold bad seeds. One major processor has been sued by contractors for failure to make payments on construction. For much of the supply chain, reality isn't living up to the hemp hype."
"We think that once the FDA has done so, the industry is likely to move forward swiftly. The new retailers of CBD products, initially focused on just topical products, will be able to add ingestible products most likely, working with a limited number of high quality producers. Additionally, FDA accountability is likely to kill off the fly-by-night operators who have entered the space. In addition to complying with the federal regulatory landscape, CBD manufacturers will need to comply with separate state-level regulations, many of which haven't yet been finalized. In our view, the market will improve dramatically once there is regulatory clarity."
***
NEW CANNABIS VENTURES
Friends,
As we suggested in our Sunday newsletter last weekend, "7 Key Questions for Cannabis Companies During Earnings Season", we expect to learn a great deal from publicly traded cannabis companies this earnings season, and we were a bit surprised this week to see the update from CV Sciences depict the CBD market in such disarray. The company reported a 25% decline year-over-year in sales. This follows weak results from competitor Elixinol Global for the quarter as well.
While we have been cautious on the CBD space, as shared privately three months ago to subscribers of 420 Investor, the situation is apparently worse than we had expected. CV Sciences CEO Joe Dowling explained on the conference call that competition has intensified greatly in the natural product space, with more than 1000 new brands competing for shelf space. He pointed to low quality products with misleading marketing efforts and labeling crowding the shelves and creating customer confusion.
Readers are likely familiar with the moves made by many food, drug and mass market retailers to enter the space, but most of these stores are focused solely on topical products due to FDA regulatory concern. These products don't have the same consumer usage intensity as the more traditional ingestible products and aren't yet contributing significantly to top-line growth.
We continue to see the media regularly reporting the disappointment of farmers growing hemp. They are finding it difficult to find buyers and face lower prices than they expected. Litigation abounds, as well, with several cases of rampant fraud, including some companies that have allegedly sold bad seeds. One major processor has been sued by contractors for failure to make payments on construction. For much of the supply chain, reality isn't living up to the hemp hype.
While Congress legalized hemp more than a year ago, the regulatory environment is quite uncertain. At the federal level, progress has been made, with the USDA recently establishing the U.S Domestic Hemp Production Program, but the FDA hasn't yet finalized its regulatory oversight over CBD products. We think that once the FDA has done so, the industry is likely to move forward swiftly. The new retailers of CBD products, initially focused on just topical products, will be able to add ingestible products most likely, working with a limited number of high quality producers. Additionally, FDA accountability is likely to kill off the fly-by-night operators who have entered the space. In addition to complying with the federal regulatory landscape, CBD manufacturers will need to comply with separate state-level regulations, many of which haven't yet been finalized. In our view, the market will improve dramatically once there is regulatory clarity.
This week will see even more cannabis companies reporting, including Charlotte's Web, the leader in the CBD space, so we look forward to hearing how it has been faring in the "Wild West" that has developed since the Farm Act became law. Several analysts cut their estimates for the company following the CV Sciences earnings release, but none expect sales to decline, as they did for CV Sciences and Elixinol, from the $25 million reported in Q3.
Bob Norris is what's missing in society
Original 'Marlboro Man' Bob Norris dead at 90 https://www.foxnews.com/entertainment/marlboro-man-bob-norris-dead
Lol - fair point.
Senate confirmation hearing for Dr. Hahn’s appointment as FDA Commissioner set for Nov. 20
https://www.foodsafetynews.com/2019/11/senate-confirmation-hearing-for-dr-hahns-appointment-as-fda-commissioner-set-for-nov-20/
“This is a crucial perspective at a time when FDA is implementing the 21st Century Cures Act, regulating tobacco and vaping products, addressing the opioid crisis, and protecting our nation’s food supply.”
Gottlieb's tweets on FDA nicotine reduction... past few hours... something coming soon?:
"The question of if FDA should regulate tobacco was resolved by Congress a decade ago and it’s one of FDA’s most important public health missions. Continuing to drive down smoking rates and reverse youth ecig use must remain top priority for FDA and broader public health community."
"One of my most important acts was the comprehensive plan we unveiled to reduce nicotine in combustible products to accelerate declines in smoking."
"The regulation of tobacco products was one of the most productive uses of my time as FDA Commissioner. There was perhaps no more impactful public health effort I was able to dedicate myself to than trying to reduce smoking rates. I’m proud of FDA’s continued role in this mission."
"Safety must be the first principle. And appropriate claims grounded in science. CBD is not safe and has largely unproven benefits outside a small subset of very carefully studied indications. The vast majority of claims being made by illegal producers will never be substantiated."
"FDA can start with supplements and put burden on producers to prove CBD safety at very low levels while ensuring manufacturing standards, purity, minimum levels of active ingredient during a transition period of enforcement discretion - and sweep market of non compliant products."
"CBD hype has outpaced science. And there are risks. But with use widespread, the question is whether FDA can help oversee quality, purity, potency and help prevent third rate purveyors from flooding market with shoddy products outside regulatory purview."
Breakthrough in CDC vaping illness investigation: Vitamin E acetate and THC may be to blame
https://www.cnn.com/2019/11/08/health/vaping-injury-vitamin-e-thc-bn/index.html
Read this article... can we just partner and have Cliff/Bruce make magic?
https://www.marketwatch.com/story/ex-canopy-ceo-bruce-linton-joins-us-cannabis-company-vireo-health-2019-11-07
Juul Labs to stop sales of mint-flavored nicotine pods in U.S.
https://www.reuters.com/article/us-juul-flavors/juul-labs-to-stop-sales-of-mint-flavored-nicotine-pods-in-us-idUSKBN1XH2PB
Zelda’s Phase II Insomnia Clinical Trial Fully Enrolled
https://clients3.weblink.com.au/pdf/ZLD/02169989.pdf
CVS chief: Getting rid of tobacco taught us an important lesson
https://www.cnn.com/2019/09/09/perspectives/cvs-tobacco-purpose/index.html
"Hope, it is the quintessential human delusion, simultaneously the source of your greatest strength, and your greatest weakness."
Where to place our hope?
A good synopsis of where we are in EOY 2019... can the real politicians please stand up?
https://www.washingtontimes.com/news/2019/nov/5/fda-must-protect-teens-but-not-deny-smokers-the-be/
Do submit your questions to investor relations.
WILLIAMSVILLE, NY -- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, Very Low Nicotine Content (VLNC) tobacco, and hemp/cannabis plant research, announced today that the Company will provide a business update for investors via an audio-only webcast on Friday, November 8, 2019, at 9:00 AM Eastern time.
Cliff Fleet, Chief Executive Officer of 22nd Century Group, together with John Brodfuehrer, Chief Financial Officer, will conduct the webcast. Interested parties are invited to listen to the live event on the 22nd Century website: www.xxiicentury.com/media/2019Q3BusinessUpdate.
The webcast will consist of an overview of recent business highlights and a review of the Company's third quarter 2019 financial results. A recording of the webcast will be available approximately one hour after completion of the event and will be archived on 22nd Century’s website for 90 days. Investors, analysts and members of the media interested in submitting questions in advance can do so by sending an e-mail with your question(s) to InvestorRelations@xxiicentury.com.
Nope
All out
Long...
Still believe we're close...
Either way - I still believe.
Feel free to crucify me 11/1.
Enjoy the weekend.
For thought... recent tweets:
Scott Gottlieb, MD Retweeted
Aetion, Inc. @aetioninc
20h hours ago
From my experience at @US_FDA, I can tell you, transformative change is happening. The resources are now there, new budgets are funding new paradigms. It says a lot about what the mood is there. - @ScottGottliebMD #aetionsummit
Scott Gottlieb, MD Retweeted
U.S. Surgeon General @Surgeon_General
19h hours ago
Our children are NOT an experiment. We know that nicotine exposure during adolescence & young adulthood can cause addiction & harm the developing brain. Learn what you can do to prevent youth use:
http://e-cigarettes.surgeongeneral.gov
Thanks for this. I inferred many months before, even prior to Cliff's appointment, that PM was sincere about smoke-free and I was scoffed at. Not out of good faith... more out of mandate. Connecting several dots.
It's coming.
brooklyn, I've got a cigar bar picked out in New Jersey.
Old news - not relevant friend. If I recall they gave up a huge stake for like 1 mil...
We will disrupt combustible cig industry... one can infer with PM licensing or buyout
Let's not forget the former CEO of Philip Morris-USA is our CEO...
It's happening... soon... and I'll be clear - soon in XXII lingo might be slightly longer than usual... but, soon enough. NPRM, PMTA, MRTP... let's go. Start with an October NPRM, please.
Or... before the new rule goes into effect. When's that?
Or... any pending applications may be waived from adhering to the new rule?
Who knows.
Good news... we're getting there... almost there...
*shivering*
So... cold...
New Cannabis Ventures:
One of the big surprises over the past few years has been the relative dearth of publicly-traded cannabis companies with a technology focus. The few that exist haven't been particularly successful in the stock market, and most investors have been more focused on companies that are involved in the cultivation, processing or selling of cannabis.
We think now is the time for investors and operators to pay particular attention to technology as an investment or as a point of differentiation among cannabis companies. This week, Flowhub, a cannabis retail management platform, announced a $23 million capital raise, so clearly there is interest in private companies involved in helping the cannabis industry scale.
In addition to retail, there are many different problems companies are trying to address, including compliance, data analytics and process improvement. Other areas of technology include physical solutions to improving yields, through lighting, genetics and nutrients, as well as better extraction methods and techniques. Additionally, especially in light of the current health crisis, technology can help produce safer extracts and hardware for vaping.
In particular, an area ripe for innovation is beverages. As Canada 2.0 kicks in, several businesses, some with backing from leading beverage companies globally, are focused on a market segment that has disappointed to date in state-legal American markets, but innovations in this area can help improve the demand, through more rapid onset and consistent dosing along with taste-masking and other attributes. We have heard a lot of promise, and we look forward to learning about new beverages as they are released in the next few months.
For investors, pure-play cannabis technology investments may be worth pursuing, but we think the importance of this theme extends to the analysis of direct cannabis operators, as we expect companies who invest in or acquire proprietary technologies will differentiate themselves in a crowded field of competitors.